Posts Tagged ‘FDA’

The oppressive heel of stifling government regulation

October 28, 2012

The recent meningitis outbreak, with dozens of deaths and hundreds of serious illnesses has been traced to a facility that was filthy, and was exempt from government regulations and inspections concerning the production of drugs.

First, remember that all the massive regulation ALREADY in place did NOTHING to stop the sale of these supposedly contaminated batches of medications. This is the cost of losing caveat emptor.

If the government regulated used car sales like they do medications, nobody would be able to afford one anymore!

When you have a populace that is educated according to the individual convictions of each one’s parents, and has not had its minds zombified by having a nanny state government that guarantees an omniscient ability to protect it from all corporate evils, then you have a populace that regulates the hell out of the markets.

We have MORE of that today with government regulation. The FDA is a big drug-pusher, if for the ones who have the right cozy relationship with the proper agent-in-charge.

The FDA and the Agriculture Department have done more to destroy the health of the nation’s people than help them.

Stores that sell healthy nutrition and healthy food have been relegated to a dark niche market restricted to the rich and those who appreciate the difference, because those who sell it have been censored by rules that “regulate” medical claims.

Marijuana could help some people in some cases in pain and in other ways but THE REGULATORS “protect us” by telling us it is as bad as heroin.

If health food bakeries tell the truth, they are slapped down with punitive fines. There have been businesses bragging about benefits. If you aren’t a BIG corporation that can pay for a $5 million study, you can’t tell what you know is the truth about a product.

Drugs are advertised all day on your favorite TV programs. Listen to the big long disclaimer list in those ads, and then think about the fact that those omniscient superhuman beings that said they could market and advertise (think your dictators) are the same omniscient superhuman beings that say marijuana is just as dangerous as heroin and cannot be prescribed or taken for any use whatsoever.

Oh and don’t forget HEMP that has no recreational effect at all!

Oh what divine wisdom we entrust to both our elected officials and to the bureaucracy that hires the divine wisdom of characters that prefer to be little regulation dictators.

Oh yeah, we’re so dumb we need to be told what we can eat, buy, sell, drink, drive, or THINK.

If you think that scandal was bad, you should have seen the stories about the VETERANS ADMINISTRATION hospital in South Florida a few years ago, where things were truly and really filthy.

As you know, that’s a government facility.

Ron Paul’s Statement on Introducing the Compassionate Freedom of Choice Act

September 28, 2012

Fda (Photo credit: Wikipedia)

Mr. Speaker, I rise to introduce the “Compassionate Freedom of Choice Act.” This legislation allows terminally ill patients to use drugs, treatments and devices that have not yet been approved by the Food and Drug Administration (FDA) if their physicians certify: (i) such patients have no other treatment options; and (Ii) the patient executes written, informed consent that they are aware of any potential risks from the drug, device, or treatment.

Here’s a chance to prove that we can all work together on behalf of terminally ill patients. All that compassion to “let them just die” can be turned to something we can all agree is good.

After all, look now, how the FDA rushed to protect the public from the dangers of Vitamin B6, and protect what demagogues call “the free market”, by which they mean the shackles of a government ban on a substance every body needs for survival:

FDA Looking to Ban B6 Supplements, Give Boost to Big Pharma:

Note the part that says Pyridoxiamine is a natural form of the vitamin:

Human beings cannot live without vitamin B-6. It is also important for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions. Its effect on carpal tunnel can seem almost miraculous.

A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.

So why is it again that we have such a benevolent government that convinces us to deny denying the cancer patients that suffer the worst pain that ever afflicts a person while awaiting death, and deny them new (and old) treatments that might have a chance of helping them if they want it. But then some governments make it easy for them to die right now. That’s “dignity” and some even call it compassion, but they won’t advocate for setting drugs free from the shackles of government, and don’t realize (some probably do) that they are only helping Big Pharma by demanding more central command and control.

I am for doing good to the poor, but I differ in opinion of the means. I think the best way of doing good to the poor, is not making them easy in poverty, but leading or driving them out of it. In my youth I travelled much, and I observed in different countries, that the more public provisions were made for the poor, the less they provided for themselves, and of course became poorer. And, on the contrary, the less was done for them, the more they did for themselves, and became richer.–Benjamin Franklin

Plastic surgery tragedy proves caveat emptor is better than government regulators

March 9, 2012
English: Source: FDA-OCI

Image via Wikipedia

Plastic Surgery Nightmare For a Texas Woman | Fox News Latino:

Here we go again. The statists will say things like this need more regulation. By which they mean more regulations written by government employees or more laws written by Congressional aides. (With apologies to the few who might write their own proposals).

The regulatory regime has lulled too many people to somnolence with the idea that the government is on top of everything and that it should prevent anything bad from happening to us.

That’s the solution, they think, to bad doctors, incompetent doctors doing bad things to their patients.

But then that just shifts the discussion to the one-size-fits-all solution, a government panel to set the rules by decree, and it does not fit all, not at all.

For example. Some people are more willing to take the risk. For new treatments that cost more because they have not had historical traction, why should a millionaire who is dying of cancer have to wait for a costly government process if he wants to take the risk and has the money to finance the first attempts at a possible cure for what ails him?

As it is now, a drug company is required to finish three years of experimentation on rats, and another three years of experimentation on humans, and another study demanded by someone on the last review panel.

Once upon a time I met a guy who had distribution rights in the United States for a new idea to reduce the facial wrinkles that come with age, and to firm up skin on younger folks. The obvious market would be women –and some men of course. It was just a type of bag with a substance similar to the packets used to keep things cold in refrigerators and in styrofoam, and I have no idea whether it works except that the idea was convincing and this guy seemed decent enough, and the company already had convincing traction in Columbia, South America.

It could be sold in the United States without the FDA approval, and with the claims for firming up skin, according to the friend, but it would be open for any kind of liability suit someone might bring. So he said anyway, but I know of companies that have been shut down for any kind of claim whatsoever that somebody at an FDA desk decides is “medical”, even true things. Like healthy amounts of fruit helps keep your immune system healthy. Can’t say that while you’re selling oranges, unless you finance a study.

Not making that up, no-sir-ee.

The FDA study that would have protected him from lawsuits cost about $3,000. Not much compared to what a lot of drug studies have cost the big companies. This wasn’t a drug and it was external, and its most important ingredient was sealed inside a strong flexible plastic, and its use was basically merely the cooling factor.

But the packaging material touches the skin, and there is that cooling factor, so the study was required. And… that without any promise that there would not be more requests following.

The friend was a retiree, and had a comfortable monthly income, and after the surprise he got had decided he did not want to bother with the investment, especially when the final decision lay not in the results but in the whim of a bureaucrat.

People who demand more government control over their lives and over the people they buy from and do business with, often don’t realize they are demanding to be told what to do with their own lives, more than they think. They trade off the abuse they get from private parties, private companies, so they think, to the trust they have in their government.

They forget that the members of government departments are made of the same kind of flesh as everybody else.

A guy or group in government, if you give them control over a big chunk of national commerce, economy, what is going to keep them more honest than their counterparts in a private enterprise that also have to answer to both their stockholders and to their customers, and even their employees?

So, it’s time for Golden Rule Government:

Therefore all things whatsoever ye would that men should do to you, do ye even so to them: for this is the law and the prophets. – Matthew 7:12